Nicotinell Fruit 2mg medicated chewing-gums
*Company:
Haleon Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 20 April 2023
File name
ie-spc-nicotinell-fruitgum-2mg-124-1-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through general sale
Updated on 20 April 2023
File name
ie-pil-nicotinell-fruitgum-2mg-124-1-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 24 August 2021
File name
ie-pil-nicotinell-fruitgum-2mg-124-1_clean-210722FM.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Addition of manufacturer
Updated on 26 May 2021
File name
ie-pil-txt-nicotinell-fruitgum-2mg-124-1_clean-210111FM.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
Updated on 26 May 2021
File name
ie-spc-nicotinell-fruitgum-2mg-124-1_clean-210111FM.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
Legal category:Supply through general sale
Updated on 24 December 2020
File name
ie-pil-2mg-fruit.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Free text change information supplied by the pharmaceutical company
Update to excipient warnings
Updated on 24 December 2020
File name
ie-pil-2mg-fruit.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Free text change information supplied by the pharmaceutical company
Update to the excipient warnings
Updated on 21 December 2020
File name
ie-spc-nicotinell-fruit-2mg-124-1-excipient-approved-clean-200918BC.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Supply through general sale
Updated on 17 January 2020
File name
ie-spc-nicotinell-fruit-2mg.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Shelf Life extended from 24 months to 30 months following replacement of primary packaing blister with new child-resistant senior-friendly blister packaging.
Updated on 30 April 2018
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 01 November 2016
File name
PIL_16713_344.pdf
Reasons for updating
- New PIL for new product
Updated on 01 November 2016
Reasons for updating
- Improved presentation of PIL
Updated on 27 October 2016
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
Updated on 03 October 2016
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 03 October 2016
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 03 May 2016
Reasons for updating
- New PIL for medicines.ie
Updated on 04 September 2015
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 2
“with known effect”
Section 4.2
Subheadings added and method of administration information put into separate subsection
Section 4.3
“listed in section 6.1” added
Section 4.8
Adverse events tabulated and adverse events reporting statement added
Section 10
From 18 August 2014 to 24 June 2015
Updated on 02 September 2014
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
SPC Update – Nicotinell Fruit 2mg medicated chewing-gum – 18 August 2014
Section 7
Address changed to Camberley.
Section 10
Change of date from 20 January 2012 to 18 August 2014.
Updated on 22 March 2012
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 9
Date of last renewal changed from 25 May 2005 to 20 January 2012-03-16
Section 10
Change of date from 28 January 2010 to 20 January 2012
Updated on 05 May 2010
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 6.5
Addition of 120 pack size
Section 10
Date changed from May 2009 to 28 January 2010
Updated on 29 July 2009
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 4.1 - Therapeutic indications
- Change to section 4.8 - Undesirable effects
- Change to section 9 - Date of renewal of authorisation
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 2
Addition of: Excipient(s): sorbital (0.2g), sodium (11.50mg) and butylhydroxytoluene (E321).
Section 4.1
Words ‘Nicotinell treatment is indicated for the’ have been deleted
‘Patient counselling and support normally improve the success rate’ has replaced ‘Advice and support normally improve the success rate’.
Section 4.2
Following paragraph : If an adverse event occurs with the use of the high dose form (4 mg medicated chewing-gum), use of the low dose form (2 mg medicated chewing-gum) should be considered. Replaces: If an adverse event is noted when high dose forms are initiated, this should be replaced by the lower dosage form.
Deletion of paragraph: Nicotinell gum is sugar free.
New paragraph: The initial dosage should be individualised on the basis of the patients nicotine dependence.
Section 4.3
Words ‘to nicotine’ added to hypersensitivity to any of the excipients.
Section 4.4
‘People having problems with the joint of the jawbone and….’ added before ‘denture wearers experience …..’
Addition of: ‘Because Nicotinell Fruit medicated chewing-gums contain sorbital:’ before Patients with rare hereditary conditions…….
Paragraph beginning Nicotinell Fruit 2mg has addition of words ‘contains sweeteners, including Sorbitol’.
New paragraph: ‘The gum base contains butylhydroxytoluene (E321) which may cause local irritation to mucous membranes’.
Section 4.5
Paragraph beginning ‘Smoking may lead to reduced….. words ‘reduction and’ have been deleted.
Section 4.6
Title change from ‘Use during pregnancy and lactation’ to ‘Pregnancy and lactation’.
Section 4.8
Addition of: Non dose-dependent adverse reactions are as follows: jaw muscle ache, erythema, urticaria, hypersensitivity, angioneurotic oedema and anaphylactic reactions.
New paragraph: Excessive swallowing of nicotine which is released in the saliva may, at first, cause hiccups. Those who are prone to indigestion may suffer initially from minor degrees of hyspepsia or heartburn: slower chewing will usually overcome this problem. Excessive consumption of nicotine gums by subjects who have not been in the habit of inhaling tobacco smoke, could possibly lead to nausea, faintness and headache. Increased frequency of aphthous ulcer may occur after abstinence from smoking.
Gastrointestinal disorders. New: flatulence, dyspepsia, salivary hypersecretion, stomatitis, oral pain, or pharyngolaryngeal pain. Deleted from list: indigestion, heartburn, increased salivation, irritation or sore mouth or throat.
Cardiac disorders: ‘Rare, atrial arrhythmia’ replaces ‘cardiac arrhythmias (eg atrial fibrillation)’.
New paragraph: ‘Cold sores may develop in connection with smoking cessation, but any relation with the nicotine treatment is unclear’.
New paragraph: ‘The patient may still experience nicotine dependence after smoking cessation’.
Section 5.3
New paragraph: ‘Nicotine was positive in some in vitro genotoxicity tests but there are also negative results with the same test systems’. Replaces: ‘No definite conclusion can be drawn on the genotoxic activity of nicotine in vitro’.
Section 6.5
Addition of box containing 204 pieces of gum.
Section 6.6
‘Used Nicotinell medicated chewing-gum should be disposed of with care’, replaces, ‘No special requirements’.
Section 9
Date of last renewal changed from
Section 10
Date of revision of the text changed from
Updated on 15 July 2008
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale